Translated with AI
Following the non-extension of the Mutual Recognition Agreement (MRA) with the European Union on May 26, 2021, Switzerland embarked on an autonomous regulatory path. While Swissmedic’s direction is aligned with European principles, the Swiss system stands as a parallel regulatory framework that, for manufacturers, represents an additional challenge rather than a true simplification.
Two recent communications from Swissmedic, both in August 2025, confirm this trend:
- activation of the UDI registration module on the national Swissdamed database;
- publication of a new fact sheet on Systems and Procedure Packs (SPP).
Both initiatives, while within the trend of harmonization with the European Union, maintain specific requirements that manufacturers must manage in parallel.
Swissdamed: Mandatory UDI Registration from 2026
The most significant news is the activation of the UDI Devices module on Swissdamed, the Swiss database for the traceability of Medical Devices.
Currently, UDI code registration is optional, but it will become mandatory from July 1, 2026, for all devices placed on the Swiss market, with a transitional period until December 31, 2026.
However, for devices that have been subject to serious incidents, Field Safety Corrective Actions (FSCA), or that show adverse event trends, the registration obligation will apply, without a transitional period, as early as July 1, 2026.
Swissdamed is the Swiss equivalent of EUDAMED, but it is a separate platform with its own specificities. For non-Swiss manufacturers operating through a CH-REP, this translates into managing a database parallel to EUDAMED, with a potential increase in administrative and operational workload. Compatibility with EUDAMED-compliant XML files mitigates the issue but does not completely eliminate the complexity of dual management.
Systems and Procedure Packs (SPP): Clarifications and Reinforcements
Swissmedic Fact Sheet MU600_00_018 (04.08.2025) more precisely defines the requirements for SPPs (Systems and Procedure Packs). It reiterates many aspects already outlined in the European Medical Device Regulation (MDR) and the Swiss Medical Devices Ordinance (MedDO), but with a specific focus on the Swiss market.
Among the main points:
- Assembler’s Declaration: the assembler is obligated to attest to the compatibility of the devices, correct packaging, and the adoption of adequate internal monitoring methods.
- SPP as a Stand-Alone Device: a pack is considered a stand-alone medical device and must therefore undergo a complete conformity assessment procedure if it contains devices without a CE mark, presents non-compliant combinations, or has undergone invalid sterilization.
- Labeling and IFU: the requirements of MDR Annex I are reiterated, with particular attention to the Swiss context.
- Vigilance: assemblers and, where applicable, the CH-REP, remain responsible for reporting serious incidents and FSCAs to Swissmedic.
Alongside these consolidated elements, the fact sheet clarifies specific requirements for Switzerland:
- The obligation to designate a CH-REP even for the SPP if assembled or sterilized abroad;
- The need to register with Swissmedic within 3 months of first placing on the market (Art. 55 MedDO);
- Confirmation that product information must be available in the three official languages (DE, FR, IT), with limited derogations;
- Transitional provisions for SPPs: SPPs compliant with previous law can remain on the market only if they comply with current provisions, while it is no longer possible to notify new packs under Art. 12 MDD.
In summary, this is not a “new regime” but an interpretative reinforcement that makes the framework for Swiss operators more stringent and structured.
Outlook for Manufacturers
While alignment with European regulations facilitates understanding of the rules, the implementation of separate systems is challenging. To overcome this, it is essential to initiate careful strategic compliance planning that integrates and optimizes procedures for access to both the European and Swiss markets.
The Thema experts are available to support you as your CH-REP with regulatory compliance for the Swiss market and with requirements for conformity to European regulations.
